Simvastatin Aurobindo

Italy
Brand name Simvastatin Aurobindo
Form tablets, film-coated
Active substance / Dosage
SIMVASTATIN
Prescription type Prescription only
ATC code
C10AA01
Registration number 038770
Manufacturer AUROBINDO PHARMA (ITALIA) S.R.L.

Table of Contents

Package leaflet: Information for the user

Simvastatina Aurobindo 10 mg film-coated tablets, 20 mg film-coated tablets, 40 mg film-coated tablets

Generic medicine
Please read this leaflet carefully before taking this medicine because it contains important
information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any questions, ask your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, because it may be harmful.
  • If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

  1. What Simvastatina Aurobindo is and what it is used for
  2. What you need to know before taking Simvastatina Aurobindo
  3. How to take Simvastatina Aurobindo
  4. Possible side effects
  5. How to store Simvastatina Aurobindo
  6. Contents of the pack and other information

1. What Simvastatin Aurobindo is and what it is used for

Simvastatin Aurobindo is a medicine used to lower the levels of total cholesterol, "bad" cholesterol (LDL cholesterol), and fatty substances called triglycerides in the blood. This medicine also increases the levels of "good" cholesterol (HDL cholesterol). This medicine belongs to a class of medicines called statins.

Cholesterol is one of several types of fat found in the bloodstream. Total cholesterol is made up mainly of LDL cholesterol and HDL cholesterol.

LDL cholesterol is often called "bad" cholesterol because it can accumulate in the walls of arteries, forming plaques. Over time, this plaque buildup can lead to narrowing of the arteries. This narrowing can slow down or block blood flow to vital organs such as the heart and brain. This blockage of blood flow may cause a heart attack or stroke.

HDL cholesterol is often called "good" cholesterol because it helps prevent "bad" cholesterol from building up in the arteries and protects against heart disease.

Triglycerides are another form of fat present in the blood that may increase the risk of heart disease.

You must follow a cholesterol-lowering diet while taking this medicine.

This medicine is used in addition to diet to lower cholesterol if you have:

  • elevated levels of cholesterol in the blood (primary hypercholesterolaemia) or elevated levels of triglycerides in the blood (mixed hyperlipidaemia);
  • an inherited condition (homozygous familial hypercholesterolaemia) that increases cholesterol levels in the blood. You may also receive other treatments;
  • coronary heart disease (CHD) or are at high risk of CHD (because you have diabetes, have had a stroke, or have other blood vessel diseases). This medicine may prolong your life by reducing the risk of heart disease, regardless of your blood cholesterol levels.

In most people, high cholesterol does not cause any immediate symptoms. Your doctor can measure your cholesterol with a simple blood test. Visit your doctor regularly, keep track of your cholesterol levels, and inform your doctor about your results.

2. What you need to know before taking Simvastatin Aurobindo

DO NOT USE Simvastatin Aurobindo

  • if you are allergic to simvastatin or any of the other ingredients of this medicine (listed in section 6);
  • if you currently have liver problems;
  • if you are pregnant or breastfeeding;
  • if you are taking a medicine containing one or more of the following active substances:
    • itraconazole, ketoconazole, posaconazole or voriconazole (used to treat fungal infections);
    • erythromycin, clarithromycin or telithromycin (used to treat infections);
    • HIV protease inhibitors such as indinavir, nelfinavir, ritonavir and saquinavir (HIV protease inhibitors are used for HIV infections);
    • boceprevir or telaprevir (used to treat hepatitis C virus infection);
    • nefazodone (used to treat depression);
    • cobicistat;
    • gemfibrozil (used to lower cholesterol);
    • ciclosporin (used in organ transplant patients);
    • danazol (an artificial hormone used to treat endometriosis, a condition in which the lining of the uterus grows outside the uterus).
  • If you are taking or have taken within the last 7 days an oral or injectable medicine called fusidic acid (a medicine used to treat bacterial infection). The combination of fusidic acid and Simvastatin Aurobindo can cause serious muscle problems (rhabdomyolysis). Do not take more than 40 mg of simvastatin if you are taking lomitapide (used to treat a rare, severe genetic cholesterol condition).

Ask your doctor for advice if you are unsure whether the medicine you are taking is one of those listed above.
Warnings and precautions
Talk to your doctor or pharmacist before taking Simvastatin Aurobindo.

  • Inform your doctor about your medical conditions, including allergies.
  • Inform your doctor if you consume large amounts of alcohol.
  • Inform your doctor if you have ever had liver disease. This medicine may not be suitable for you.
  • Inform your doctor if you are about to undergo surgery. You may need to stop taking this medicine temporarily.
  • If you are of Asian descent, as a different dose may be appropriate for you.

Your doctor will perform a blood test before you start taking Simvastatin Aurobindo and if you develop symptoms of liver problems while taking Simvastatin Aurobindo. This test is performed to check whether your liver is functioning properly.
Your doctor may also prescribe blood tests to monitor liver function after starting treatment with this medicine.
While taking this medicine, your doctor will monitor you closely if you have diabetes or are at risk of developing diabetes. You are at risk of developing diabetes if you have high levels of sugar and fats in your blood, are overweight, and have high blood pressure.
Inform your doctor if you have a severe lung disease.
Contact your doctor immediately if you experience unexplained muscle pain, tenderness or weakness. This is because, in rare cases, muscle problems can be serious and include damage to muscle tissue leading to kidney damage; deaths have occurred very rarely.
The risk of muscle problems is higher at higher doses of this medicine, particularly at the 80 mg dose. The risk of muscle injury is also increased in certain patients.
Talk to your doctor if any of the following conditions apply to you:

  • if you consume large amounts of alcohol;
  • if you have kidney problems;
  • if you have thyroid problems;
  • if you are 65 years of age or older;
  • if you are female;
  • if you have had or have ever had muscle problems while being treated with cholesterol-lowering medicines called "statins" or fibrates;
  • if you or a close family member have inherited muscle disorders.

In addition, inform your doctor or pharmacist if you have persistent muscle weakness.
Additional tests and treatments may be needed to diagnose and manage this condition.
Children and adolescents
The safety and efficacy of Simvastatin Aurobindo have been studied in boys and girls aged 10 to 17 years and in girls who have had menstrual periods (menstruation) for at least one year (see section 3, "How to take Simvastatin Aurobindo"). Simvastatin Aurobindo has not been studied in children under 10 years of age. For further information, consult your doctor.
Other medicines and Simvastatin Aurobindo
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those without a prescription. Taking Simvastatin Aurobindo with any of these medicines may increase the risk of muscle problems (some of which have already been listed in the previous section "Do not take Simvastatin Aurobindo"):

  • if you need to take oral fusidic acid to treat a bacterial infection, you must temporarily stop taking this medicine. Your doctor will tell you when it is safe to restart treatment with Simvastatin Aurobindo. Taking Simvastatin Aurobindo with fusidic acid may rarely cause muscle weakness, pain or tenderness (rhabdomyolysis). See further information on rhabdomyolysis in section 4;
  • ciclosporin (a medicine often used in organ transplant patients);
  • danazol (a synthetic hormone used to treat endometriosis, a condition in which the lining of the uterus grows outside the uterus);
  • medicines with an active substance such as itraconazole, ketoconazole, fluconazole, posaconazole or voriconazole (used to treat fungal infections);
  • fibrates with an active substance such as gemfibrozil and bezafibrate (used to reduce cholesterol);
  • erythromycin, clarithromycin, telithromycin (used to treat bacterial infections);
  • HIV protease inhibitors such as indinavir, nelfinavir, ritonavir and saquinavir (used to treat AIDS);
  • antiviral agents for hepatitis C such as boceprevir, telaprevir, elbasvir or grazoprevir (used to treat hepatitis C virus infections);
  • nefazodone (used to treat depression);
  • medicines containing the active substance cobicistat;
  • amiodarone (used to treat irregular heartbeat);
  • verapamil, diltiazem or amlodipine (used to treat high blood pressure, chest pain associated with heart disease, or other heart conditions);
  • lomitapide (used to treat a rare, severe genetic cholesterol condition);
  • daptomycin (a medicine used to treat complicated skin and skin structure infections and bacteremia). Muscle-related side effects may be increased when this medicine is taken during treatment with simvastatin. Your doctor may decide to temporarily stop treatment;
  • colchicine (used to treat gout).

As with the medicines listed above, inform your doctor or pharmacist if you are taking or have recently taken any other medicine, including those without a prescription. In particular, inform your doctor if you are taking a medicine containing any of the following active substances:

  • medicines with an active substance to prevent blood clots, such as warfarin, phenprocoumon or acenocoumarol (anticoagulants);
  • fenofibrate (also used to lower cholesterol);
  • niacin (also used to lower cholesterol);
  • rifampicin (used to treat tuberculosis);
  • ticagrelor (antiplatelet agent).

You must also inform any doctor who is prescribing you a new medicine that you are taking Simvastatin Aurobindo.
Simvastatin Aurobindo with food and drink
Grapefruit juice contains one or more substances that alter how the body processes certain medicines, including Simvastatin Aurobindo. Avoid consuming grapefruit juice.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Do not take this medicine if you are pregnant, trying to become pregnant, or think you might be pregnant. If you become pregnant while taking this medicine, stop treatment immediately and contact your doctor.
Do not take this medicine if you are breastfeeding, as it is not known whether the medicine is excreted in breast milk.
Driving and using machines
This medicine is not expected to affect your ability to drive or operate machinery. However, you should be aware that some people may experience dizziness after taking this medicine.
Simvastatin Aurobindo contains lactose
Simvastatin Aurobindo tablets contain a sugar called lactose; if your doctor has diagnosed you with an intolerance to certain sugars, contact your doctor before taking this medicine.

3. How to take Simvastatina Aurobindo

Your doctor will determine the appropriate tablet dosage for you, based on your condition, current treatment, and risk profile.
Take this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor or pharmacist.
Follow a cholesterol-lowering diet while taking this medicine.

Dosage:
The recommended dose is 1 tablet containing 5 mg, 10 mg, 20 mg, 40 mg, or 80 mg of Simvastatina Aurobindo, taken orally once daily.

Adults:
The usual starting dose is 10 mg, 20 mg, or, in some cases, 40 mg per day. Your doctor may adjust the dose after at least 4 weeks, up to a maximum of 80 mg daily. Do not take more than 80 mg per day.
Your doctor may prescribe a lower dose, especially if you are taking any of the medicines listed above or have certain kidney problems.
The 80 mg dose is recommended only for adult patients with very high cholesterol levels and a high risk of heart problems who have not achieved their desired cholesterol level with lower doses.

Use in children and adolescents
The recommended starting dose for children (from 10 to 17 years of age) is 10 mg once daily in the evening. The maximum recommended dose is 40 mg per day.

Method of administration:
Take Simvastatina Aurobindo in the evening. It can be taken with or without food. Continue taking this medicine unless your doctor tells you otherwise.
If your doctor has prescribed Simvastatina Aurobindo together with another cholesterol-lowering medicine containing a bile acid sequestrant, you must take Simvastatina Aurobindo at least 2 hours before or 4 hours after taking the bile acid sequestrant medicine.

If you take more Simvastatina Aurobindo than you should

  • Contact your doctor or pharmacist immediately.

If you forget to take Simvastatina Aurobindo

  • Do not take a double dose to make up for the missed dose. Take only your usual dose at the regular time the next day.

If you stop taking Simvastatina Aurobindo

  • Talk to your doctor or pharmacist, as your cholesterol levels may rise again.

If you have any doubts about how to use this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
The following terms are used to describe how often the side effects occur:

  • Rare (may affect up to 1 in 1,000 people).
  • Very rare (may affect up to 1 in 10,000 people).
  • Not known (the frequency cannot be estimated from the available data).

The following rare serious side effects have been reported.
If you experience any of these serious side effects, stop taking this medicine immediately
and contact your doctor or go to the nearest hospital emergency department.
Muscle pain, tenderness, weakness, muscle breakdown or cramps. In rare cases, these muscle problems can be severe, including breakdown of muscle cells leading to kidney damage; cases of death have occurred, although very rarely.
Hypersensitivity reactions (allergies) including:
swelling of the face, tongue and throat which may cause breathing difficulties (angioedema);
acute muscle pain usually felt in the shoulders and hips;
rash with weakness of limbs and neck muscles;
rash which may appear on the skin or in mouth ulcers (drug-induced lichenoid eruptions);
joint pain or inflammation (polymyalgia rheumatica);
inflammation of blood vessels (vasculitis);
unusual bruising, skin rash and swelling (dermatomyositis), hives, skin sensitivity to sunlight, fever, redness;
shortness of breath (dyspnea) and feeling unwell;
lupus-like illness (including skin rash, joint disorders and effects on blood cells).
Inflammation of the liver with the following symptoms: yellowing of the skin and eyes, itching, dark urine or pale stools, feeling tired or weak, loss of appetite, liver failure (very rare).
Inflammation of the pancreas, often associated with severe abdominal pain.
The following side effects have been reported rarely:
Low red blood cell count (anaemia).
Numbness or weakness in arms and legs.
Headache, tingling sensation, dizziness.
Blurred vision, altered vision.
Digestive disturbances (abdominal pain, constipation, flatulence, indigestion, diarrhoea, nausea, vomiting).
Skin rash, itching, hair loss.
Weakness.
Sleep difficulties (very rare).
Poor memory (very rare), memory loss, confusion.
The following very rare serious side effect has been reported:
A severe allergic reaction causing breathing difficulties or dizziness (anaphylaxis).
Gynaecomastia (breast enlargement in men).
The following adverse effects have also been reported, but their frequency cannot be estimated from the available data (frequency not known):

  • Erectile dysfunction.
  • Depression.
  • Inflammation of the lungs causing breathing problems including persistent cough and/or asthma or fever.
  • Tendon problems, sometimes complicated by tendon rupture.

Additional possible adverse effects reported with some statins:

  • Sleep disorders, including nightmares.
  • Sexual problems.
  • Diabetes. This is more likely if you have high levels of sugar and fats in your blood, are overweight, and have high blood pressure. Your doctor will monitor you while you are taking this medicine.
  • Persistent muscle pain, tenderness or weakness that may not resolve after stopping treatment with this medicine (frequency not known).

Laboratory findings
In laboratory tests, increases in certain liver function values and in a muscle enzyme (creatine kinase) have been observed.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Simvastatin Aurobindo

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the blister and on the cardboard box
following the word EXP. The expiry date refers to the last day of that month.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Simvastatina Aurobindo tablets contain

  • The active substance is simvastatin. Each film-coated tablet contains 10 mg of simvastatin. Each film-coated tablet contains 20 mg of simvastatin. Each film-coated tablet contains 40 mg of simvastatin.
  • The other components are: Tablet core Butylated hydroxyanisole (E320), Ascorbic acid (E300), Citric acid monohydrate (E330), Microcrystalline cellulose (E460a), Pregelatinized maize starch, Lactose monohydrate, Magnesium stearate (E470B)

Film coating
Hypromellose (E464), Hydroxypropylcellulose (E463), Titanium dioxide (E171), Talc (E553b), Iron oxide yellow (E172) – for 10 and 20 mg, Iron oxide red (E172) – for 10, 20, 40 mg

Description of the appearance of Simvastatina Aurobindo and contents of the pack
Film-coated tablets.
Simvastatina Aurobindo 10 mg film-coated tablets:
light pink, round [diameter 6.1 mm], biconvex, with an "A" on one side and "01" on the other.
Simvastatina Aurobindo 20 mg film-coated tablets:
light pink, round [diameter 8.1 mm], biconvex, with an "A" on one side and "02" on the other.
Simvastatina Aurobindo 40 mg film-coated tablets:
pink, round [diameter 10.1 mm], biconvex, with an "A" on one side and "03" on the other.
Simvastatina Aurobindo 10, 20 and 40 mg film-coated tablets are available in blister packs containing 10, 14, 20, 28, 30, 50, 56, 60, 84, 90, 98 and 100 tablets.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Aurobindo Pharma (Italia) S.r.l.
Via San Giuseppe, 102
21047 - Saronno (VA)
Italy

Manufacturers
Milpharm Limited
Ares, Odyssey Business Park
West End Road
South Ruislip HA4 6QD
United Kingdom
APL Swift Services (Malta) Limited
HF26, Hal Far Industrial Estate, Hal Far
Birzebbugia, BBG 3000
Malta

This medicinal product is authorized in the European Economic Area countries under the following names:
France: SIMVASTATINE ARROW LAB 10/20/40 mg, comprimés pelliculés
Germany: Simvastatin PUREN 5/10/20/40/80 mg Filmtabletten
Italy: Simvastatina Aurobindo
Poland: Simvastatin Aurovitas
Portugal: Simvastatina Aurobindo
Romania: Simvastatin Aurobindo 10/20/40 mg comprimat filmat
Spain: Simvastatina Aurovitas 10/20/40 mg comprimidos recubiertos con película
Netherlands: Simvastatine Aurobindo 5/10/20/40/80 mg filmomhulde tabletten
United Kingdom: Simvastatin 10/20/40/80 mg film-coated tablets